Tidal Volume Challenge and Reliability of Plethysmography Variability Index

NCT03546179 | Completed

• 1 other identifier: D154
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate whether a temporary increase in tidal volume can predict fluid responsiveness in patients receiving a low tidal volume ventilation in hepatobiliary and pancreatic surgeries. The hypothesis of this study is that a temporary increase in tidal volume from 6 to 8 ml/kg would improve the predictability of PVI in patients receiving low tidal volume ventilation in surgical procedures with large fluid shift as hepatobiliary and pancreatic procedures.

Conditions

Abdominal Cancer

Keywords

PVI, Tidal volume challenge

Outcome Measures

Primary Outcomes (1)

• detection of best cut-off value of ΔPVI6-8 by using tidal volume challenge.

  By Youden index \[sensitivity + (specificity - 1)\]

  2 minutes after performing a "tidal volume challenge"

Secondary Outcomes (35)

• Detection of sensitivity of PVI6 measured by masimo radical 7 equipment..

  2 minutes before tidal volume challenge when tidal volume of patient is 6ml/kg

• Detection of specificity of PVI6 measured by masimo radical 7 equipment..

  1 minute before tidal volume challenge when tidal volume of patient is 6ml/kg

• Detection of best cut off of percentage ΔPVI6-8 measured by masimo radical 7 equipment.

  2 minutes after performing tidal volume challenge

• Detection of sensitivity of ΔPVI6-8 measured by masimo radical 7 equipment.

  2 minutes after performing tidal volume challenge

• Detection of sensitivity of percentage ΔPVI6-8 measured by masimo radical 7 equipment.

  2 minutes after performing tidal volume challenge

Other Outcomes (13)

• age

  once when patient is recruited

• sex

  once when patient is recruited

• Height

  once when patient is recruited

Interventions

tidal volume challenge test OTHER

Tidal volume (VT) will be increased from 6 to 8 ml/kg of for one minute and hemodynamic variables, including PVI with 8 ml/kg tidal volume ventilation (PVI8) will be recorded.

Volume loading OTHER

After these two baseline hemodynamic measurements, volume expansion will be performed for 10 min using an infusion of balanced crystalloid solution (6ml/kg of predicted body weight).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years undergoing hepatic, pancreatic or biliary tumor resection

You may qualify if:

• Patients older than 18 years undergoing hepatic, pancreatic or biliary tumor resection

You may not qualify if:

• Preoperative cardiac arrhythmias
• Peripheral vascular disease
• Low left ventricular function (ejection fraction \< 40%)
• Significant valvular heart disease
• Intra-cardiac shunts
• Pulmonary hypertension
• Fulminant hepatic failure.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

National Liver Institute

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

Related Publications (7)

• Tympa A, Theodoraki K, Tsaroucha A, Arkadopoulos N, Vassiliou I, Smyrniotis V. Anesthetic Considerations in Hepatectomies under Hepatic Vascular Control. HPB Surg. 2012;2012:720754. doi: 10.1155/2012/720754. Epub 2012 May 28.

  PMID: 22690040 RESULT

• Navarro LH, Bloomstone JA, Auler JO Jr, Cannesson M, Rocca GD, Gan TJ, Kinsky M, Magder S, Miller TE, Mythen M, Perel A, Reuter DA, Pinsky MR, Kramer GC. Perioperative fluid therapy: a statement from the international Fluid Optimization Group. Perioper Med (Lond). 2015 Apr 10;4:3. doi: 10.1186/s13741-015-0014-z. eCollection 2015.

  PMID: 25897397 RESULT

• Joshi GP. Intraoperative fluid restriction improves outcome after major elective gastrointestinal surgery. Anesth Analg. 2005 Aug;101(2):601-605. doi: 10.1213/01.ANE.0000159171.26521.31.

  PMID: 16037184 RESULT

• Smyrniotis V, Kostopanagiotou G, Theodoraki K, Tsantoulas D, Contis JC. The role of central venous pressure and type of vascular control in blood loss during major liver resections. Am J Surg. 2004 Mar;187(3):398-402. doi: 10.1016/j.amjsurg.2003.12.001.

  PMID: 15006570 RESULT

• Michard F, Teboul JL. Using heart-lung interactions to assess fluid responsiveness during mechanical ventilation. Crit Care. 2000;4(5):282-9. doi: 10.1186/cc710. Epub 2000 Sep 1.

  PMID: 11094507 RESULT

• Michard F, Schmidt U. Prediction of fluid responsiveness: searching for the Holy Grail. J Appl Physiol (1985). 2004 Aug;97(2):790-1; author reply 791. doi: 10.1152/japplphysiol.00021.2004. No abstract available.

  PMID: 15247205 RESULT

• Myatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.

  PMID: 27922879 RESULT

Study Officials

• Magdy K Mohamed Khalil, M.D

  National Liver Institute, Menoufia University

  STUDY CHAIR

• Mohamed F Mohamed El-Gayar, M.D

  Faculty of medicine, Fayoum University

  STUDY DIRECTOR

• Joseph M Botros, M.D

  Faculty of medicine, Fayoum University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 6, 2018
• Study Start: August 1, 2018
• Primary Completion: January 15, 2020
• Study Completion: February 15, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

EG (1)